Alturas Advisor
Fall/Winter 2017-18
Meet ALICE
(Alturas Lab Interface Communications Equipment) Information System
A connected workflow is required for a bioanalytical laboratory to operate with high productivity and efficiency. Communications, lab supplies, equipment lists, test methods, project management, and invoicing have traditionally been managed in separate locations with individualized design and use, creating an inefficient and unproductive system. Being a rapidly growing business, Alturas Analytics has grappled with decisions around the best business system to manage expanding operations.
Alturas Analytics has designed a fully integrated system to monitor laboratory operations from initial client contact to invoice creation to sample disposition that yields shorter times to data and final reports with a great degree of confidence.
Antibody Drug Conjugates (ADC)
Experience
Ten years of assay development experience with Antibody Drug Conjugates (ADCs) has given Alturas Analytics the depth of knowledge to produce accurate and consistent measurements of ADCs in accordance with FDA guidelines. Our expert team possesses understanding of the critical factors inherent to ADC assay development that is applied to each unique project. . . Read More About ADCs
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2016-2017
A Better Diagnostic Test for Tuberculosis:
GC-MS/MS Bioanalysis for the Determination of the Biomarker D-Arabinose in Urine
A collaborative article with The Global Good Fund and Alturas Analytics, Inc.
Alturas Analytics, Inc. excels in the ability to solve problems and meet the 21st century’s demands in the treatment of disease. The future of bioanalysis is the convergence of drug development with clinical diagnostics (biomarkers) and we remain dedicated to the managed expansion of our throughput capacity and the variety of services offered in our laboratory.
Tuberculosis is a global pandemic found in every country in the world and is the leading cause of infectious death worldwide. Close to 10 million people worldwide are estimated to have fallen ill with TB in 2014. Diagnosis of pulmonary TB is challenging and involves clinical assumptions with abnormal chest x-rays and analysis of sputum for the TB bacteria. . .
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2015-2016
Crystal City VI: Assay Criteria and Level of Validation Required for Biomarkers Will Depend Upon the Intended Purpose of the Assay
By Jennifer Zimmer, Ph.D.
At the AAPS-FDA Crystal City VI meeting, regulators and industry gathered to discuss the draft bioanalytical method validation guidance and how it relates to the assay of biomarkers, both by LC-MS and by immunoassay. One thing was clear throughout, biomarker assays are not PK assays; however, some of the tests used in the validation of PK assays are still relevant for the validation of biomarker assays. In addition, there is a wealth of knowledge that has been gathered over the last 25 years by the clinical chemistry community who operate under CLIA guidelines. While CLIA may not be entirely applicable to the bioanalytical validation of biomarker assays, there are portions of the CLIA regulations that can be adapted for use in this purpose. . .
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2014-2015
Expanding Bioanalytical & Biomarker Capabilities: Addition of TSQ Quantum XLS Ultra™ GC-MS/MS
Alturas Analytics, Inc. excels at addressing the bioanalytical industry’s demands for sensitivity, selectivity, robustness and ease-of-use through our unmatched expertise and continued acquisition of top-shelf instrumentation. With our thoughts turned toward the future, we remain dedicated to the managed expansion of our throughput capacity and the variety of services offered in our laboratory. . .
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2013-2014
Driving Innovation in Regulated Bioanalysis through Microflow Liquid Chromatography and High Flow Nanospray Mass Spectrometry
Research continues at Alturas Analytics into Microflow Liquid Chromatography (MFLC) for its application in a regulated bioanalytical laboratory. As the technology improves and we refine our techniques, the advantages of this system become more self-evident. Last year the Alturas team successfully validated an assay for the analysis of methotrexate in plasma using MFLC-MS/MS. Since then our team has conducted numerous experiments and presented the use of MFLC-MS/MS under several conditions, in varying matrices and for differing purposes. . .
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2012-2013
Micro Flow Liquid Chromatography (MFLC)-MS/MS Bioanalytical Research
Last year in our newsletter, we discussed the enthusiasm we had for our initial research of MFLC-MS/MS use in support of bioanalytical projects. After presenting more data over the past year, MFLC-MS/MS created a big buzz at events such as ASMS and NBC. We are happy to say that interest in the technique is growing and Alturas Analytics continues to lead the way in implementing the technique in bioanalytical
laboratories. . .
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2011-2012
LC-MS/MS Bioanalysis of Macromolecules: Proteins and Biomarkers
As LC-MS/MS technology advances to improve instrument sensitivity and selectivity, applications of the technology continue to expand. Recently, pharmaceutical and biotech organizations have expanded their research to macromolecules in order to enhance their drug development pipeline. Additionally, the monitoring of biomarkers (both large and small molecules) is playing a larger role in drug discovery and development. Bioanalysis of these macromolecules has traditionally been performed with the use of ligand binding assays (LBA). . .
Read the entire newsletter:
____________________________________________________________________________________
Alturas Advisor
Fall/Winter 2010-2011
Research Advances with Dried Blood Spot Analysis (DBS) Coupled with LC/MS/MS
In our newsletter last year, we posed the question,“Will dried blood spot (DBS) analysis become a routine tool accepted by bioanalysts, clinicians, toxicologists and PK scientists to support drug development programs?” Although the technique is still in its infancy in the pharmaceutical industry, the past year has seen DBS technology emerge into an accepted bioanalytical tool. Many organizations,including AAPS and ASMS, have devoted entire conference sessions to the technique and plan to include sessions in their upcoming meetings. Interest continues to grow, and we are proud to say that Alturas Analytics is one of the leaders in this exciting bioanalytical research field.....
Read the entire newsletter:
____________________________________________________________________________________